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This is an example CRF used to collect general concomitant medications/products in a study. This CRF was designed to allow the applicant to use either CMENRF or CMENRTPT to represent an intervention was ongoing. The code list to be used for unit is specified by the applicant and no shown.. 



This is the metadata specifications for Section 1 and 2 of the CRF.  

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Were any concomitant medications/products taken?Any Concomitant Medications/ProductsIndicate if the subject took any concomitant medications/products. If Yes, include the appropriate details where indicated on the CRF.Text


(NY)

Section 2 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the category for the concomitant medication/product?Concomitant Medication/Product CategoryRecord the medication/product category, if not pre-printed on the CRF.CMCATCMCAT


GENERAL
3What is the medication/product line number?CM Line NumberIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.CMSPIDCMSPID




4What was the medication/product?Concomitant Medication/ProductRecord only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.CMTRTCMTRT




5For what indication was the medication/product taken?IndicationRecord the reason the medication/product was taken based on clinical investigator's evaluation. If taken to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If taken to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as "Prophylaxis for " and include a description of the condition(s).CMINDCCMINDC




6What was the individual dose of the medication/product?DoseRecord the dose of medication/treatment per administration (e.g., 200).CMDSTXTCMDOSTXT OR CMDOSECMDOSTXT/  CMDOSE



7What is the unit?UnitRecord the dose unit of the dose of medication/product taken (e.g., mg).CMDOSUCMDOSU
(UNIT)CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug

8What was the dose form of the medication/product?Dose FormRecord the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the medication/product  taken.CMDOSFRMCMDOSFRM
(FRM)AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET

9What was the frequency of the medication/product?FrequencyRecord how often the medication/product was taken (e.g., BID, PRN).CMDOSFRQCMDOSFRQ
(FREQ)BID; PRN; QD; QID; QM; QOD; TID

10What was the route of administration of the medication/product?RouteProvide the route of administration for the medication/product.CMROUTECMROUTE
(ROUTE)INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL

11What was the start date?Start DateRecord the date the  medication/treatment was first taken using this format. If the subject has been taking the medication/product for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date.  Medications/Products taken during the study are expected to have a complete start date. Prior  medications/products that are exclusionary should have both a start date and an end date.CMSTDATCMSTDTC




12Is the medication ongoing?OngoingRecord the  medication/product as ongoing if the subject has not stopped taking the  medication/product at the time of data collection and the end date should be left blank.CMONGOCMENRF OR  CMENRTPTCMENRF or CMENRTPT(NY)Yes

13What was the end date?End DateRecord the date the  medication/product was stopped using this format  If the subject has not stopped taking the  medication/product leave this field blank.CMENDATCMENDTC









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